Putting Electroencephalography (EEG) in the Emergency Department
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01355211|
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : March 2, 2012
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
The aim of the proposed research is to compare the diagnostic accuracy of a portable wireless electroencephalography (EEG) device (Biosignal Micro-EEG) to standard EEG in identifying abnormal EEG patterns (mainly non-convulsive seizure and non-convulsive status epilepticus) in emergency department (ED) patients with altered mental status. Comparing the the accuracy of EEG recordings and interpretations of Micro-EEG to those of standard EEG will allow the investigators to assess the utility of this novel device in the ED patients with altered mental status. The unique qualities of Micro-EEG device could potentially facilitate easier access to EEG test in all ED patients.
This study will also provide valid information regarding the prevalence of non-convulsive seizure in ED patients with altered mental status.The gold standard for diagnosing non-convulsive seizure would be standard EEG.
All study participants will undergo electroencephalography using the two devices (standard EEG and micro-EEG) and a combination of standard electrodes and Electro-Cap in a randomized order: 1. Standard EEG with standard EEG electrodes, 2. Micro-EEG with standard EEG electrodes, and 3. Micro-EEG with Electro-Cap electrodes.
|Condition or disease|
|Altered Mental Status Generalized Nonconvulsive Seizure Disorder Status-epilepticus|
Formulated Research Question:
Population: ED patients with altered mental status (AMS) Intervention: Micro-EEG Comparison: Standard EEG Outcomes: 1. Sensitivity, specificity, positive/negative likelihood ratios of micro-EEG in identifying non-convulsive seizures and abnormal brain activities 2. The concordance of EEG interpretations between micro-EEG and standard EEGs recordings Design Prospective cross-sectional
Altered Mental Status: Any acute change in level of arousability or responsiveness (e.g. confusion, lethargy, delirium, coma, aphasia, disinhibition, labile/blunted affect or unexpected psychosis).
Types of AMS (for the purpose of the study):
- AMS alone
- AMS with non-specific motor activity (subtle motor movement such as eye blinking, nystagmus, focal motor movements, or myoclonus)
- Prolonged AMS following one or more tonic-clonic seizures suggesting status epilepticus Non-convulsive seizure (NCZ):A seizure without clonic or tonic activity or other convulsive motor activity.
Status Epilepticus (SE):SE is defined as 1. More than 30 minutes of continuous seizure activity or 2. Two or more sequential seizures without recovery of consciousness between seizures.
|Study Type :||Observational|
|Actual Enrollment :||261 participants|
|Official Title:||Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients With Altered Mental Status|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
- Diagnostic Utility of Emergency Electroencephalography in Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status (AMS) [ Time Frame: 6 months ]
- Sensitivity, specificity, positive/negative likelihood ratios of micro-EEG in identifying non-convulsive seizures and abnormal brain activities
- The concordance of EEG interpretations between micro-EEG and standard EEG recordings
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||13 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
ED patients ≥ 13 year-old with AMS on arrival to ED
Patients with apparent and immediately correctable cause of AMS upon presentation (determined by ED attending physician during initial evaluation):
- Patients with finger stick or serum glucose less than 60 mg/dl
- Patients with hypothermia
- Patients with hyperthermia, heat exhaustion or heat stroke
- Patients with opioid overdose responding to Narcan
- Patients who cannot undergo EEG recordings because of severe head and injury, hemodynamic instability, transfer to operating room, etc.)
- Hemodynamically unstable patients (SBP < 90 mmHg)
- Uncooperative or combative patients on whom the EEG simply cannot be obtained.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355211
|United States, New York|
|450 Clarkson Avenue|
|Brooklyn, New York, United States, 11203|
|Principal Investigator:||Shahriar Zehtabchi, MD||Recruiting|
|Responsible Party:||Bio-Signal Group Corp.|
|Other Study ID Numbers:||
RC3NS070658 ( U.S. NIH Grant/Contract )
RC3NS070658 ( U.S. NIH Grant/Contract )
|First Posted:||May 18, 2011 Key Record Dates|
|Last Update Posted:||March 2, 2012|
|Last Verified:||February 2012|
Altered Mental Status
Nervous System Diseases
Central Nervous System Diseases